Although COVID-19 manifests itself differently in men and women, the vast majority of current clinical studies of SARS-CoV-2 and COVID-19 do not mention gender. In fact, only a fraction, 4 percent, explicitly plan to include gender differences in their studies, a new analysis of nearly 4,500 studies concludes.
There were clear differences between men and women in the corona pandemic. Men are more vulnerable to a severe course of COVID-19, more men are hospitalized, and more men die from the effects of the virus. We don’t know exactly why that is. The consequence may be that men and women need different therapies. At the same time, there is a link between gender and the risk of contracting an infection, for example, because women are more likely to work in healthcare or in other positions with direct contact with other people. This increases the chance of exposure to the virus. When doing research and making policy, it is important to pay attention to both elements.
Lack of attention to gender problematic
Still, only a minority of the 4,420 registered clinical studies on COVID-19 mention the sex of the subjects, according to a new analysis published in Nature Communications. The study was conducted by researchers from Radboudumc, Aarhus University, Copenhagen University, and Bielefeld University.
According to researcher Sabine Oertelt-Prigione of Radboudumc and the University of Bielefeld, the lack of attention to gender is problematic: “We have seen from the start that the disease does not have an identical course for women and men. The differences in hospital admission and death rates This means that our care, such as drugs or other treatments, can also lead to different results.”
4 percent include gender in research
The researchers looked at 4,420 COVID-19 studies registered with ClinicalTrials.gov, a US database of more than 300,000 studies from 200 countries. In the COVID-19 sample, 1,659 were observational studies, and 2,475 were intervention studies.
- 21.2 percent include gender when recruiting participants
- 4 percent plan to include gender in the results
- 5.4 percent say gender distribution is important
- 2.8 percent focused on one gender (including 100 women studies, often focused on pregnancy).
Investigating under time pressure
One reason for the lack of data on gender may be that the studies are conducted under great time pressure. Sabine Oertelt-Prigione: “Researchers are sometimes concerned that analyzing sex differences in a study could mean more participants and longer recruitment times to achieve their goals. Especially in the early stages of the pandemic, they worked under great time pressure.”
Researcher Emer Brady, who works at the Danish Center for Studies in Research and Policy at Aarhus University, adds: “In terms of time constraints, we hoped that as the pandemic progressed and more attention was paid to gender differences, there would be more focus on gender in the study protocols that were registered on ClinicalTrials.gov, but that turned out not to be the case. We also looked at the published trials, where the focus on gender was greater, but still took or reported only one in five trials included gender in their analyses.”
Oertelt-Prigione emphasizes the importance of the role of gender in clinical research: “We are increasingly seeing that men and women respond differently to drugs. Ignoring this in trials can later lead to serious unwanted side effects. By looking at gender differences, we have identified the infection. understand better and we will learn more about treatment options. Taking gender differences into account is an essential step towards more personalized healthcare.”